DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contribution

Monday, 13 June 2016

Yanli Mi

Yanli Mi

Summary

• A driven and energetic pharmaceutical professional. Always improving self and embracing new challenges. Good at communication and teamwork.

• Ten plus years of industry experience in pharmaceutical and biological arenas working with interdisciplinary teams and managing CMOs / CROs domestically and internationally, I provided technical leadership for early / late stages of various drug development (Small and large molecules).

• Proficient at cGMP requirements with ICH, USP and FDA guidelines, I provided successful global regulatory and technical support gaining FDA and EMEA approval. I also mastered effective negotiation, problem solving, strategic planning, collaborative teamwork, interpersonal relationship, communication and other leadership skills, with an emphasis on efficiency, compliance, business logistics and result-oriented for project management, budgets, milestones, timelines and deliverables.

Experience

• Support the analytical activities and CMC sections for two approved HIV combination therapies (two, three and four drug single tablet regimens) Descovy and Genvoya.
• Lead a group of 8 scientists and associates for the data review and quality control for successful NDA submission for recently approved HIV combination therapy (three drug single tablet regimens) Odefsy.
• Oversee, coordinate and summarize reports for the development and QC activities at contract research/testing labs for method validation, method transfer, primary stability, and bulk hold time studies to support both CMC sections of regulatory submissions, to respond to questions from regulatory agencies/health authorities, and to support several programs of the clinical, market and post-approval manufacturing campaigns.
• Execute analytical method development and validation, and author validation and stability reports for Ebola project in clinical phase, for both solution and lyophilized formulations.

Extensive data review for clinical and commercial quality control groups from Gilead and its various contract manufacturers, including commercial / clinical stability and release data packages, and analytical method validation for API and drug products of more than ten projects, including the most well-known Gilead HIV (single, two, three and four drug into single tablet regimens, the previous and the current generations) and HCV market products (including Savoldi and Harvoni).

April 2011 – December 2013 (2 years 9 months)San Francisco Bay Area -China

• Owner of self-registered Current Pharmaceuticals, a platform to consult and collaborate various projects, including supporting API and drug product manufacture, outsourcing, analytical method and formulation development, drug delivery technology, quality assurance, animal and PK studies, business development, and regulatory considerations for CMOs and start-ups in China.
• Co-founder.
• Assisted with Sichuan Pharmaceuticals Inc. and Sichuan Ke Chuang Pharmaceutical Group to identify and introduce new nutritional and therapeutic candidates into their future pipeline.

• Managed a group of 5 scientists and associates to lead four projects (phase I to phase III monoclonal antibody, phase II peptide, post-market and life cycle management small molecule market products) for the formulation and process development in house, and by collaborating and transferring projects among CMO/CRO organizations.
• Coordinated internal pre-formulation and formulation studies, lead selection, stability program management, scalable manufacturing process, alternative devices evaluation (pre-filled syringe vs vials), optimization of liquid and lyophilization processes.
• Improved the formulation and process by directly or indirectly participating the stability and compatibility studies of formulation screening by using various analytical methods, such as, HPLC-(SEC,RP,IEC,HIC), cell-, immune- (ELISA, etc), capillary electrophoresis-(CE-SDS), particle analysis (HIAC,AUC) and spectroscopy-based (UV,FT-IR, CD, Fluorescence) methods, and by characterizing biochemical and biophysical properties or devices, proteins and their degradation products.
• Authored scientific posters, publications and regulatory filing and responded to FDA questions.
• Led or supported different stages of due diligence activities from scientific aspects to showcase projects for company merge and acquisition efforts. Transferred the entire QC and stability data archives from Minnesota to California site before acquisition.

• Project lead for oncology and HIV Phase III lyophilized products representing the process development and technology transfer team, working with internal labs, cross-site organizations and CMOs to trouble shoot and resolve any QA investigations, and contributed to successful NDA filing.
• Improved the overall liquid lab capacity for sterile product development, including new technology evaluation and introduction, equipment and process validation.
• Ensured supply of small and large scale (scale up and down) clinical and commercial batches by leading technology development / transfer for sterile and tablet products (formulation / process / packaging / labeling / manufacturing parameters) to and from external labs and CMOs.

• Established sales channels and negotiated business agreements / terms / conditions for all OTC products in the Beijing region.
• Co-developed and executed marketing strategies, by working with consulting companies such as McKinsey, and with both wholesale and retail sellers.
• Promoted awareness of Novartis market products by regular product presentations, national and regional conferences, pharmacy and hospital visits, and placement of subway, public space for posters, light boxes and TV advertisements.

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MAVEN

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.

Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker.

He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc.

He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, he has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 20 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto

He lives and will die for his family, 90% paralysis cannot kill his soul. Notably he has 9.5 lakh views on New Drug Approvals Blog in 211 countries..................click here

He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

OLD BIO

DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,

Currently he is working with GLENMARKPHARMA LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.

Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now RPG lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 29 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.

He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published worldwide .

He suffered a paralytic stroke in dec 2007 and is bound to a wheelchair, this seems to have injected feul in him to help chemists around the world, he is more active than before and is pushing boundaries, he has one lakh connections on all networking sites, He makes himself available to all, contact him on +91 9323115463, amcrasto@gmail.com, Twitter @amcrasto